SBIR-STTR Award

Liquid chromatography (LC) is the most important analytical technique in the pharmaceutical industry. Currently available LC instruments on the market suffer from high cost and large size, contrary to the general trend of miniaturization within the field of analytical instrumentation. Axcend Corporation has developed a compact LC platform weighing 7 kg while still maintaining similar performance to the more traditional LC models. In this Fast-Track SBIR project, researchers at Axcend Corporation in collaboration with capillary LC instrumentation experts at Rowan University, two LC column manufacturers, and several leading international pharmaceutical manufacturers, will adapt this compact LC instrument to fulfill the needs in the pharmaceutical industry. In Phase I, the capability of the instrument to meet regulatory guidelines in terms of chromatographic performance and data auditing will be demonstrated. Once completed, Phase II will involve the use of the system in a number of relevant pharmaceutical applications. A high-throughput gradient LC screening method will be developed to identify impurities in new chemical entities. The system will also be coupled to both batch and process manufacturing streams for on-line reaction monitoring in real-time. New capillary LC columns will be developed to enhance the separation of protein-based therapeutics (antibody-drug conjugates, or ADCs) and then applied to the full workflow required to characterize these ADCs. All of these aims will be achieved by using the Axcend compact LC system, which is smaller, has a lower cost, is simpler to use, and reduces solvent waste over 1,000-fold over traditional LC methodology.

Public Health Relevance Statement:
Project Narrative The safety and efficacy of pharmaceutical drugs requires extensive analytical testing using liquid chromatography. This project focuses on the development of a compact capillary liquid chromatography system that can be used for quality control testing, batch and continuous process monitoring, and other chemical analysis needs in the pharmaceutical industry. The ability to test both small molecule compounds and larger biopharmaceutical drugs throughout their development process will be demonstrated with this new instrument.

Project Terms:
analytical tool; Antibody-drug conjugates; Area; base; Biological Products; Blood capillaries; capillary liquid chromatography; Chemicals; Chromatography; Collaborations; Column Chromatography; commercialization; Computer software; computerized data processing; cost; Cost Savings; Coupled; Coupling; Data; data acquisition; Detection; Development; Drug Industry; Gold; Guidelines; Industry Standard; Injections; instrument; instrumentation; International; Life Cycle Stages; Liquid Chromatography; liquid chromatography mass spectrometry; Manufacturer Name; manufacturing process; Mass Spectrum Analysis; Measures; method development; Methodology; Methods; Miniaturization; Modeling; Modernization; Monitor; Monoclonal Antibodies; operation; particle; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacopoeias; Phase; portability; Process; Proteins; Quality Control; Reaction; Refuse Disposal; Reporting; Research; research and development; Research Personnel; Safety; Sampling; Savings; screening; Small Business Innovation Research Grant; small molecule; software systems; Solvents; Sorbus; Stream; System; Techniques; Technology; Testing; Therapeutic antibodies; Time; trend; United States; Universities; wasting

Liquid chromatography (LC) is the most important analytical technique in the pharmaceutical industry. Currently available LC instruments on the market suffer from high cost and large size, contrary to the general trend of miniaturization within the field of analytical instrumentation. Axcend Corporation has developed a compact LC platform weighing 7 kg while still maintaining similar performance to the more traditional LC models. In this Fast-Track SBIR project, researchers at Axcend Corporation in collaboration with capillary LC instrumentation experts at Rowan University, two LC column manufacturers, and several leading international pharmaceutical manufacturers, will adapt this compact LC instrument to fulfill the needs in the pharmaceutical industry. In Phase I, the capability of the instrument to meet regulatory guidelines in terms of chromatographic performance and data auditing will be demonstrated. Once completed, Phase II will involve the use of the system in a number of relevant pharmaceutical applications. A high-throughput gradient LC screening method will be developed to identify impurities in new chemical entities. The system will also be coupled to both batch and process manufacturing streams for on-line reaction monitoring in real-time. New capillary LC columns will be developed to enhance the separation of protein-based therapeutics (antibody-drug conjugates, or ADCs) and then applied to the full workflow required to characterize these ADCs. All of these aims will be achieved by using the Axcend compact LC system, which is smaller, has a lower cost, is simpler to use, and reduces solvent waste over 1,000-fold over traditional LC methodology. Public Health Relevance Statement Project Narrative The safety and efficacy of pharmaceutical drugs requires extensive analytical testing using liquid chromatography. This project focuses on the development of a compact capillary liquid chromatography system that can be used for quality control testing, batch and continuous process monitoring, and other chemical analysis needs in the pharmaceutical industry. The ability to test both small molecule compounds and larger biopharmaceutical drugs throughout their development process will be demonstrated with this new instrument.